Skip to main content
OpenTrials
Completed

NCT Number: NCT02294695

Early Procalcitonin Kinetics During Empirical Antibiotic Therapy in Critically Ill Patients

To investigate the value of procalcitonin (PCT) kinetics between 0-8-16-24 hours after starting empirical antibiotic therapy in critically ill patients, to predict appropriate or inappropriate antibiotic treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology and Intensive Therapy

Szeged, Csongrád megye, H-6725, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical signs of infection
  • Suspected or proven acute infection requiring empiric antibiotic therapy as decided by the attending ICU physician
  • Suspected site of infection has to be present and documented
  • Microbiological sample sent for staining
  • Inflammatory markers available at the start of the therapy

Exclusion criteria

  • Patients younger than 18 years
  • Who received prophylactic or empiric antibiotic therapy 48 hours before inclusion
  • Whose receiving acute renal replacement therapy in the first 24 hours following antibiotic treatment
  • Following cardiopulmonary resuscitation
  • End stage diseases with a "do not resuscitate" order
  • Immunocompromised patients (human immunodeficiency virus infection, bone marrow transplantation, malignant haematological disorders and chemotherapy)
  • Post cardiac surgery patients

Treatment and study plan

Primary outcomes

  1. Procalcitonin kinetic

    Time frame: The first six days after starting empiric antibiotic treatment

    PCT levers are measured every 8 hours in the first day after starting empiric antibiotic treatment then daily and the changes in percentage are followed form the baseline value measured right before the first exposition of the antibiotic therapy.

Secondary outcomes

  1. Sequential Organ Failure Assessment score

    Time frame: The first six days after starting empiric antibiotic treatment

    SOFA score is measured every day after starting empiric antibiotic treatment.

Other outcomes

  1. Length of Intensive Care Unit stay

    Time frame: Maximum 90 days after enrollment

  2. Intensive Care Unit mortality

    Time frame: Maximum 90 days after enrollment

  3. Length of hospital stay

    Time frame: Maximum 90 days after enrollment

  4. Hospital mortality

    Time frame: Maximum 90 days after enrollment

Sponsors and collaborators

Lead sponsor

Domonkos Trásy

Other

Registry information

Official study title

Early Procalcitonin Kinetics May Indicate Effectiveness of the Empirical Antibiotic Therapy in Sepsis Within Hours

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 19, 2014
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.